NCT06758375RecruitingPhase 2
Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients
Low-dose Teclistamab As Consolidation in the First-line Treatment of Patients with Newly Diagnosed Multiple Myeloma.
Source: ClinicalTrials.gov · Last updated 20 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This single-arm, open-label study aims to determine the efficacy and safety of low-dose, limited-duration teclistamab as a consolidation scheme in newly diagnosed multiple myeloma (NDMM) patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 Dec 2024
- Start date
- Mar 2025
- Primary completion date
- Sept 2026
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Diseases
- Multiple myeloma
- NCT number
- NCT06758375
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From Mar 2025 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous treatment for MM.
- Vaccination with live attenuated virus in the 4 weeks prior to teclistamab administration.
- Major surgery during the 2 weeks prior to the first dose or absence of complete recovery from surgery.
- Presence of other concomitant malignancy.
- Women of childbearing age: active pregnancy prior to the first administration of treatment.
Other illness
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes) or AL amyloidosis.
- Severe active infection secondary to viruses, bacteria or fungi.
- Pulmonary disease requiring supplemental oxygen.
- History of allogeneic or autologous hematopoietic cell transplantation.
- Hepatitis B and C virus infection or human immunodeficiency virus (HIV) infection.
- Cerebrovascular events or seizures in the last 6 months.
- Congestive heart failure class III-IV according to NYHA (New York Heart Association Stage).
- Acute myocardial infarction or history of coronary revascularization surgery in the last 6 months.
Other
- Active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
Who the study is looking for
- ≥18 years of age.
- Newly diagnosed multiple myeloma.
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.
- Women of childbearing potential must have a negative serum pregnancy test prior to starting treatment and agree to use a highly effective method of contraception, such as a hormonal method that inhibits ovulation, an intrauterine device, or a vasectomy partner.
- Males: agree to use a highly effective contraceptive method, such as a male condom or vasectomy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez Coordinator of this site? Confirm its status | Monterrey | Mexico | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.